Understand the potential for interference

The three things laboratorians need to know about biotin interference

Our assays are purposefully designed.
Streptavidin and biotin naturally form a strong, highly specific, stable bond. This design has been used to create sensitive, accurate immunoassays for decades.

Our PK study provides valuable insights.
Studies confirm that when used as directed in our package inserts, there is no risk of interference associated with the normal intake (30-60 mcg/day) of biotin.

Growth rate of biotin has slowed in recent months.
Despite some potentially confusing information in the media, the total biotin growth rate slowed to 3.3% from July 2016 to June 2017.

Sandwich assays

Biotinylated capture antibody; analyte and ruthenylated antibody form a sandwich.

Streptavidin-coated, magnetic microparticles are added.

Excessive free biotin in the sample will compete with the biotinylated, preformed immunocomplex for binding sites on the streptavidin-coated microparticles.

The streptavidin-coated microparticles have a very high binding capacity for biotin and therefore provide some buffer capacity for free biotin in the sample. Interference will become visible only with high biotin concentrations in the sample, which are above the published threshold for each specific assay.

This will lead to falsely decreased results in sandwich assays.

Competitive assays

Biotinylated capture antibody; analyte from the samples and ruthenylated analyte are incubated.

Analyte from the sample competes with ruthenylated analyte for binding to the biotinylated capture antibody.

Streptavidin-coated, magnetic microparticles are added.

Excessive free biotin in the sample will compete with the biotinylated, preformed immunocomplex for binding sites on the streptavidin-coated microparticles.

The streptavidin-coated microparticles have a very high binding capacity for biotin and therefore provide some buffer capacity for free biotin in the sample. Interference will become visible only with high biotin concentrations in the sample, which are above the published threshold for each specific assay.

Sandwich assays

Biotinylated capture antibody; analyte and ruthenylated antibody form a sandwich.

Streptavidin-coated, magnetic microparticles are added.

Excessive free biotin in the sample will compete with the biotinylated, preformed immunocomplex for binding sites on the streptavidin-coated microparticles.

The streptavidin-coated microparticles have a very high binding capacity for biotin and therefore provide some buffer capacity for free biotin in the sample. Interference will become visible only with high biotin concentrations in the sample, which are above the published threshold for each specific assay.

This will lead to falsely decreased results in sandwich assays.

Competitive assays

Biotinylated capture antibody; analyte from the samples and ruthenylated analyte are incubated.

Analyte from the sample competes with ruthenylated analyte for binding to the biotinylated capture antibody.

Streptavidin-coated, magnetic microparticles are added.

Excessive free biotin in the sample will compete with the biotinylated, preformed immunocomplex for binding sites on the streptavidin-coated microparticles.

The streptavidin-coated microparticles have a very high binding capacity for biotin and therefore provide some buffer capacity for free biotin in the sample. Interference will become visible only with high biotin concentrations in the sample, which are above the published threshold for each specific assay.

This will lead to falsely increased results in competitive assays.

PK study provides insight

Roche completed a phamacokintetic study (n=54), detailed results can be found below. In a separate study we re-measured biotin thresholds of all Roche assays and confirmed the tolerance thresholds listed in the current package insert. Several assays were confirmed to have even higher thresholds than previously thought.

Key conclusions: Continue to utilize our broad immunoassay portfolio as you always have. Such laboratory tests are a key piece of the full clinical picture. If results of any lab test don’t seem to correspond with the complete clinical assessment of a patient, redraw the sample.

Study results by biotin dosage

Results based on 5mg/day dosage

100% of subjects in the study taking 5mg of biotin per day were below a tolerance threshold of 30ng/mL within 3.5 hours

Results based on10mg/day dosage

100% of subjects in the study taking 10mg of biotin per day were below a tolerance threshold of 30ng/mL within 8 hours

About our study design

Our pharmacokinetic study was conducted to confirm the half-life of biotin by assessing its concentrations in plasma upon daily consumption of biotin in three different doses. The study also related biotin plasma level to in vitro interference thresholds, which are assessed during the assay development process.

The study recruited 54 healthy volunteers, 18 per biotin dose group, 50% male and female in each group. Three different biotin doses were assessed — 5, 10 and 20mg per day. Biotin was taken for five days.

Blood samples were taken on days 1 and 2, before the first biotin dose, to establish an individual baseline for each person; on day 3 the biotin intake started. On the first and last day of biotin intake, samples were collected at 1, 3, 6, 8 and 12 hours after ingestion. In addition, on day 6, right before the last biotin intake, an additional blood sample was taken to assess steady-state concentrations.

This study design is widely used in pharmacokinetic studies, and the large number of data points allows for extrapolations and simulations of other concentrations and sampling time points.

PK study provides insight

Roche completed a phamacokintetic study (n=54), detailed results can be found below. In a separate study we re-measured biotin thresholds of all Roche assays and confirmed the tolerance thresholds listed in the current package insert. Several assays were confirmed to have even higher thresholds than previously thought.

Key conclusions: Continue to utilize our broad immunoassay portfolio as you always have. Such laboratory tests are a key piece of the full clinical picture. If results of any lab test don’t seem to correspond with the complete clinical assessment of a patient, redraw the sample.

Study results by biotin dosage

Results based on 5mg/day dosage

100% of subjects in the study taking 5mg of biotin per day were below a tolerance threshold of 30ng/mL within 3.5 hours

Results based on10mg/day dosage

100% of subjects in the study taking 10mg of biotin per day were below a tolerance threshold of 30ng/mL within 8 hours

About our study design

Our pharmacokinetic study was conducted to confirm the half-life of biotin by assessing its concentrations in plasma upon daily consumption of biotin in three different doses. The study also related biotin plasma level to in vitro interference thresholds, which are assessed during the assay development process.

The study recruited 54 healthy volunteers, 18 per biotin dose group, 50% male and female in each group. Three different biotin doses were assessed — 5, 10 and 20mg per day. Biotin was taken for five days.

Blood samples were taken on days 1 and 2, before the first biotin dose, to establish an individual baseline for each person; on day 3 the biotin intake started. On the first and last day of biotin intake, samples were collected at 1, 3, 6, 8 and 12 hours after ingestion. In addition, on day 6, right before the last biotin intake, an additional blood sample was taken to assess steady-state concentrations.

This study design is widely used in pharmacokinetic studies, and the large number of data points allows for extrapolations and simulations of other concentrations and sampling time points.

Biotin sales data provides clarity

While there has been market noise surrounding biotin supplement sales, it’s important to note a few key facts. An increase in overall biotin sales does not necessarily correlate to an increased risk of test interference. Lower doses (under 2.5mg) make up the majority of biotin sales, and such dosages have no influence on our immunoassay testing. Were rates to continue to grow at the current pace of 3.3 percent, it would take 22 years for purchase volumes to double.

Lower dosage levels make up the majority of sales

Majority of biotin sales are in dosages of <=2.5mg

Sales of 5mg doses have declined over the past three years

Sales of 10mg doses are significantly less than 5mg and lower doses

Growth rate has slowed in recent months

Biotin sales have been trending slightly upward in the U.S. over a three-year period from July 2014 to June 2017.

From July 2015 to June 2016, sales of all doses of biotin grew 6.4 percent over the previous 12-month period.

Total biotin sales growth is slowing in recent periods, Growth rate slowed to 3.3 percent from July 2016 to June 2017.

Biotin sales data provides clarity

While there has been market noise surrounding biotin supplement sales, it’s important to note a few key facts. An increase in overall biotin sales does not necessarily correlate to an increased risk of test interference. Lower doses (under 2.5mg) make up the majority of biotin sales, and such dosages have no influence on our immunoassay testing. Were rates to continue to grow at the current pace of 3.3 percent, it would take 22 years for purchase volumes to double.

Lower dosage levels make up the majority of sales

Majority of biotin sales are in dosages of <=2.5mg

Sales of 5mg doses have declined over the past three years

Sales of 10mg doses are significantly less than 5mg and lower doses

Growth rate has slowed in recent months

Biotin sales have been trending slightly upward in the U.S. over a three-year period from July 2014 to June 2017.

From July 2015 to June 2016, sales of all doses of biotin grew 6.4 percent over the previous 12-month period.

Total biotin sales growth is slowing in recent periods, Growth rate slowed to 3.3 percent from July 2016 to June 2017.

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